April - June 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
The drug product(s) included in any of the potential signals of serious risks/new safety information listed below may also include the generic version of the drug product(s), if there are generic versions approved for use by the FDA at the time of this publication.
| Product Name: Trade (Active Ingredient) or Product Class | Potential Signal of a Serious Risk / New Safety Information | Additional Information (as of October 24, 2025) |
|---|---|---|
| Acetadote (acetylcysteine) | Overdose |
Updated
The “Warnings and Precautions,” “Adverse Reactions,” and “Overdosage” sections of the Prescribing Information were updated in November 2024 to describe fatal outcomes associated with acetylcysteine overdosage, including hemolytic uremic syndrome, seizure/cerebral edema, and anaphylaxis. |
Aromatase inhibitors
| Tendon disorders |
Updated
The “Adverse Reactions” section of the labeling was updated in December 2024 to include information about tendon disorders. Example: Aromasin labeling |
Avonex (interferon beta-1a) Betaseron (interferon beta-1b) Extavia (interferon beta-1b) Plegridy (peginterferon beta-1a) Rebif (interferon beta-1a) | Myocardial infarction | FDA decided no action is necessary at this time based on available information. |
Bactrim (sulfamethoxazole and trimethoprim) Septra (trimethoprim and sulfamethoxazole) Sulfatrim (sulfamethoxazole and trimethoprim) Generic products containing sulfamethoxazole and trimethoprim
| Acute respiratory failure |
Updated
The “Information for Patients” section of the labeling was updated in June 2024 to include hypersensitivity and other serious reactions and expanded the list of symptoms warranting immediate medical attention. Example: Bactrim labeling |
Bafiertam (monomethyl fumarate) Tecfidera (dimethyl fumarate) Vumerity (diroximel fumarate) Generic products containing dimethyl fumarate, diroximel fumarate or monomethyl fumarate | Gastrointestinal haemorrhage | FDA is evaluating the need for regulatory action. |
Bisphosphonates
Generic products containing bisphosphonates | Non-femoral atypical fracture | FDA is evaluating the need for regulatory action. |
Brilinta (ticagrelor) Crestor (rosuvastatin) Ezallor Sprinkle (rosuvastatin) Roszet (rosuvastatin and ezetimibe) | Drug-drug interaction leading to an increased risk of rhabdomyolysis |
Updated
The “Drug Interactions” and “Clinical Pharmacology” sections of the labeling were updated between July 2024 and February 2025 to include information about the risk of rhabdomyolysis. Example: Ezallor Sprinkle labeling
|
Bylvay (odevixibat) Livmarli (maralixibat)
| Hemorrhage |
Updated
The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling were updated in March 2024 and March 2025 regarding bleeding related to fat-soluble vitamin deficiency. Example: Bylvay labeling |
Calcitonin gene-related peptide receptor antagonists
| Raynaud’s phenomenon | FDA is evaluating the need for regulatory action. |
Cholinesterase inhibitors
| Electrocardiogram QT prolonged |
Updated
The “Adverse Reactions” section of the labeling was updated for Exelon Patch in May 2024 to include information about QTc prolongation. FDA determined that no action was necessary for all other listed products at the time based on available information. |
Cholinesterase inhibitors
| Torsade de pointes |
Updated
The “Adverse Reactions” section of the labeling was updated for Exelon Patch in May 2024 to include information about torsade de pointes. FDA determined that no action was necessary for all other listed products at the time based on available information. |
Certain fluorouracil product (generic product for the trade name Efudex)
| Look alike container labels that contribute to wrong drug errors |
Updated
The container labels and carton labeling were updated for a certain generic fluorouracil product in January 2024 to minimize the risk of wrong drug errors. FDA determined that no action was necessary for a certain authorized generic product at the time based on available information. |
| Certain fluorouracil product (authorized generic product for the trade name Efudex) | ||
Enzyme replacement therapy
| Hypersensitivity |
Updated
The “Boxed Warning”, “Warnings and Precautions”, and “Patient Counseling Information” sections of the labeling were updated in July 2024 to include information about hypersensitivity. Example: Naglazyme labeling |
Gadolinium-based contrast agents
| Pancreatitis acute |
Updated
The “Adverse Reactions” section of the labeling was updated in July 2024 to include information about acute pancreatitis. Example: Prohance labeling |
Galzin (zinc acetate) Zinc Chloride Injection | Cytopenia |
Updated
The “Warnings” section of labeling was updated in April 2024 to include information on copper deficiency leading to cytopenias. Example: Galzin labeling |
| Givlaari (givosiran) | Hyperhomocysteinemia |
Updated
FDA determined that no action was necessary at the time based on available information. |
| Givlaari (givosiran) | Pancreatitis |
Updated
The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling were updated in April 2024 to include information about acute pancreatitis. |
HMG-CoA reductase inhibitors
Generic products containing HMG-CoA reductase inhibitors | Myasthenia gravis | FDA is evaluating the need for regulatory action. |
Isoniazid Nydrazid (isoniazid) Rifater (rifampin, isoniazid, and pyrazinamide) | Severe cutaneous adverse reactions |
Updated
The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling were updated in February 2025 to include information about severe cutaneous adverse reactions. Example: Isoniazid labeling |
Kalydeco (ivacaftor) Orkambi (lumacaftor and ivacaftor) Symdeko (tezacaftor/ivacaftor) Trikafta (elexacaftor, tezacaftor, and ivacaftor)
| Cataract congenital |
Updated
FDA determined that no action was necessary at the time based on available information. |
Certain loratadine product (generic product for the trade name Claritin) Certain acetaminophen and oxycodone product (generic product) | Similar tablet appearance that may contribute to wrong drug errors |
Updated
The code imprint, carton labeling, and Drug Facts Label for a certain loratadine product was updated in October 2023 to minimize the risk of wrong drug errors. FDA determined that no action was necessary at the time based on available information for the certain acetaminophen and oxycodone generic product. |
Midazolam in Sodium Chloride Injection Certain Magnesium Sulfate in Dextrose Injection (generic product) | Look alike container labels that may contribute to wrong drug errors |
Updated
The container labeling for Midazolam in Sodium Chloride was updated in July 2024 to minimize the risk of wrong drug errors. FDA determined that no action was necessary at the time based on available information for certain Magnesium Sulfate in Dextrose Injection generic product. |
| Mounjaro (tirzepatide) | Hypersensitivity | The “Contraindications”, “Warnings and Precautions”, and “Postmarketing Experience” sections of the labeling were updated July 2023 to include serious hypersensitivity reactions, including anaphylaxis and angioedema.
|
| Padcev (enfortumab vedotin-ejfv) | Allergic conditions |
Updated
FDA determined that no action was necessary at the time based on available information. |
| Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) | Accidental ingestion of product desiccant
|
Updated
The “Warnings and Precautions”, “Adverse Reactions”, Medication Guide, and "Patient Counseling Information" sections of the labeling were updated in October 2023 to include information about desiccant removal to mitigate accidental ingestion. |
| Tabrecta (capmatinib) | Thrombocytopenia |
Updated
The “Adverse Reactions” section of the labeling was updated in March 2024 to include information about thrombocytopenia. |
| Tafinlar (dabrafenib) | Radiation recall phenomenon |
Updated
FDA determined that no action was necessary at the time based on available information. |
| Tivdak (tisotumab vedotin-tftv) | Allergic conditions |
Updated
FDA determined that no action was necessary at the time based on available information. |
Vyvgart (efgartigimod alfa-fcab) Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) | Anaphylactic reaction |
Updated
The “Contraindications”, “Warnings and Precautions”, “Adverse Reactions”, and the "Patient Counseling Information" sections of the labeling were updated in December 2023 to include information about anaphylaxis. Example: Vyvgart Hytrulo labeling |
Vyvgart (efgartigimod alfa-fcab) Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) | Infusion related reaction |
Updated
The “Contraindications”, “Warnings and Precautions”, “Adverse Reactions”, and the "Patient Counseling Information" sections of the labeling were updated in December 2023 to include information about infusion related reactions. Example: Vyvgart Hytrulo labeling |